Kharkiv

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

This research aims to provide ongoing access to treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen studies that include daratumumab. It allows all participants from daratumumab studies and those in daratumumab-containing arms of related studies, which have reached clinical cutoff for final analysis, to continue treatment. The study also collects long-term safety data from these participants. The treatments being evaluated include daratumumab, which is given either intravenously or subcutaneously, carfilzomib administered intravenously, dexamethasone given orally or intravenously, and oral medications lenalidomide and pomalidomide. Participants will continue to receive these treatments as part of this long-term extension study following their previous study treatment. During the study, participants will be monitored for safety, including tracking serious adverse events, adverse events of special interest, pregnancies, and abnormal pregnancies over a period of 3 years and 7 months. Assessments include pregnancy testing for women of childbearing potential and adherence to lifestyle restrictions. Participants must provide informed consent and will be followed closely to evaluate the long-term effects and safety of their treatment.

Researchers are evaluating the effects of an injected vitamin combination versus an oral vitamin B12 alone on vitamin B12 levels in adults with vitamin B12 deficiency. This phase 4 study aims to compare changes in serum vitamin B12 concentration after 28 days of treatment. The study also assesses other markers related to vitamin B12 status, methylation, and overall well-being, including serum holotranscobalamin, homocysteine, methylmalonic acid, vitamin B6, folic acid, and quality of life questionnaires. Participants receive either an intramuscular injection of a fixed vitamin combination containing vitamin B6, vitamin B12, and folic acid or take oral tablets of vitamin B12 alone. The treatment period lasts for 4 weeks (28 days). Safety and tolerability of both treatment methods are also monitored during this time. During the study, participants undergo blood tests to measure vitamin B12 and related markers at baseline and day 28. Pregnancy tests are done at screening and on days 0, 28, and 56 for women of childbearing potential. Well-being and health surveys are completed to evaluate quality of life. Participants are monitored for safety and treatment effects throughout the study period, which includes follow-up assessments after treatment completion.

Researchers are evaluating the physical impact of multiple sclerosis (MS) from the participant's perspective while providing continued access to the drug ocrelizumab. This Phase 3 extension study focuses on assessing the safety and tolerability of ocrelizumab, a treatment for MS, at approved doses. The study includes participants who were already receiving ocrelizumab in previous Genentech and/or F. Hoffmann-La Roche Ltd sponsored studies and do not have local access to this treatment through other means. Participants will receive ocrelizumab either by intravenous (IV) infusion at 600 milligrams or by subcutaneous (SC) injection at 920 milligrams, following the dosing schedule from their previous parent study. Treatment will begin no earlier than five months after their last dose in the parent study. This open-label, multicenter extension provides ongoing access to ocrelizumab for up to five years. Throughout the study, participants will be monitored for changes in their physical functioning using the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis (PROMISnq PFMS-15a). Researchers will also track the number of participants receiving ocrelizumab during the study and assess safety and tolerability over the long term. Monitoring includes regular evaluations to ensure participant well-being during the extended treatment period.

Researchers are studying the effects of cancer diagnosis and treatment during pregnancy on both mothers and their children. The aim is to understand the overall survival of mothers diagnosed with cancer during pregnancy and to test whether children exposed to cancer treatments like chemotherapy or radiation in the womb develop normally, particularly focusing on neurological and heart health. The study includes several parts addressing maternal health during and after pregnancy and long-term follow-up of children exposed to cancer treatments before birth. The study involves registering mothers diagnosed with cancer during pregnancy and collecting maternal blood samples, umbilical cord blood, and tissue samples from the placenta and umbilical cord. Mothers complete questionnaires about anxiety and emotional needs related to their diagnosis. Children who were exposed to cancer treatments in the womb will have regular health check-ups at ages 6 months, 18 months, 3, 6, 9, 12, 15, and 18 years. After age 18, cardiologic assessments and questionnaires will continue every five years, with optional MRI scans at several ages during childhood and adolescence. Participants will be monitored through neurological and cardiological exams performed by specialists to assess the children's development. Mothers’ outcomes will be tracked prospectively from diagnosis through treatment and delivery. The study includes long-term follow-up for both mothers and children, with comprehensive assessments to evaluate health effects over many years. Participants provide informed consent, and children older than 12 provide assent with consent from parents or themselves once they reach adulthood.

Researchers are evaluating the efficacy and safety of cariprazine in treating adolescents aged 13 to 17 years with schizophrenia. This Phase 3 study compares cariprazine to a placebo to understand its effects on this population. Participants must have a confirmed diagnosis of schizophrenia based on DSM-5 criteria and meet specific symptom severity requirements. Participants receive either cariprazine or matching placebo capsules once daily by mouth for 6 weeks in a randomized, double-blind, parallel-group design. The study is conducted across multiple international centers to ensure diverse participation and data collection. Throughout the 6-week study, researchers assess changes in schizophrenia symptoms using the PANSS total score from baseline to Week 6. Safety and tolerability are also monitored closely. Participants will undergo clinical evaluations and symptom scoring to track progress and response to treatment during the study period.

Researchers are evaluating the safety and effectiveness of masitinib combined with riluzole compared to a placebo combined with riluzole for treating patients with Amyotrophic Lateral Sclerosis (ALS). Masitinib is an oral drug that targets specific cells involved in neuroinflammation, such as mast cells and microglia, which are believed to play a key role in ALS progression. This Phase 3 study is designed to better understand how masitinib may affect the disease by slowing progression and reducing inflammation in the nervous system. The study is a multicenter, double-blind, randomized, placebo-controlled trial where participants receive either oral masitinib at doses titrated to 4.5 or 6.0 mg/kg/day plus riluzole, or a matching placebo plus riluzole. Riluzole is given as a 50 mg tablet taken by mouth. The treatment period includes two ascending dose titrations for masitinib or placebo groups to compare outcomes and safety. Participants continue their stable riluzole treatment throughout the study. During the trial, participants are monitored for changes in their ALS Functional Rating Scale-Revised (ALSFRS-R) scores over 48 weeks, which measures their physical function and disease progression. Assessments include clinical evaluations and safety monitoring to track the impact of the treatments. The study enrolls adults aged 18 to 81 years who have probable or definite ALS and meet specified disease duration and function criteria. The goal is to gather detailed information on how masitinib in combination with riluzole might alter the course of ALS compared to riluzole alone.

This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.